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Penlon 53450

by Penlon, Ltd.

Penlon 53450 is a Class II device made by Penlon, Ltd., cleared under FDA 510(k) K053564 on 3 Mar 2006 and listed in FDA GUDID since 14 Feb 2017 (UDI-DI 05051977000444), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K053564

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05051977000444 UDI-DI Date14 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053564 Date3 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053564 decided 3 Mar 2006 Active
  • FDA GUDID UDI-DI 05051977000444 listed 14 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053564
  2. Listed FDA GUDID 05051977000444

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Penlon
Generic name
Isoflurane anaesthesia vaporizer
Model / Ref / Catalog
53450
Primary DI / UDI-DI
05051977000444
510(k) Number
FDA product code
CAD
GMDN term
Isoflurane anaesthesia vaporizer
Device class
Class II
Regulation number
868.5880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isoflurane anaesthesia vaporizer

Cleared under the same submission (K053564)

Similar devices

Other devices filed under FDA product code CAD (Vaporizer, Anesthesia, Non-Heated).

Other devices from Penlon, Ltd.

See all devices from Penlon, Ltd. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)